Pre-Conference Workshop

June 29, 2021

Risk Mitigation in Translation & Clinical Development of Cell Engagers

11:00 am Chair’s Opening Remarks

11:15 am Examining Toxicity Mitigation Strategies To CD3 Bispecifics In Humanized Mouse Models


• Mice can be used to model cytokine release and on-target toxicity
• Systemic cytokines can be reduced using multiple mechanisms including dexamethasone or step-dosing
• Mouse models allow the examination of toxicity mitigation strategies while examining their impact on efficacy

11:40 am Review Types and Sources of Toxicity for T-Cell Retargeting Bi and Multi-Specific Antibodies


• Review predictive approaches to foreseeing toxicity
• What we know about biodistribution and TI
• Application of computational predictive methods
• Use of in vitro testing to predict toxicity
• Use of in vivo testing to predict toxicity

12:05 pm Speaker Q&A

12:15 pm Networking Break

12:45 pm Round Table: Developing A Dosing Strategy For Clinical Trial Investigations


• Strategies for selection of starting doses to balance patient safety and minimize patient’s exposure to subtherapeutic doses
• Approaches for predicting efficacious doses
• Challenges and opportunities for defining optimal biological doses for CD3 bispecifics

1:15 pm Networking Break

1:45 pm Developing Combination Approaches Using Immunocompetent Vk*MYChCRBN Genetically Engineered Humanized Model Of Multiple Myeloma


• Advantages of preclinical investigation of T cell engagers in syngeneic tumor animal models
• Rational combination of T cell engagers with standard of care therapy
• Exploring combinations to promote tempered and more durable antitumor efficacy

2:10 pm Developing A Preclinical Biomarker Strategy For Assessing Efficacy and Safety of Bispecific T Cell Engagers

  • Maya Kotturi Director of Preclinical Biomarkers , IGM Biosciences


• Bispecific CD20xCD3 IgG antibodies are clinically efficacious but are
associated with significant toxicity, especially cytokine release syndrome
• IGM-2323 is a novel engineered high-affinity, high-avidity anti-CD20
pentameric IgM antibody, with an anti-CD3 scFv fused to the joining (J) chain
• Our preclinical data demonstrate IGM-2323 is highly effective at
complement dependent cytotoxicity and T-cell dependent cellular
cytotoxicity killing of tumor cells with minimal cytokine release,
especially in comparison to bispecific IgG antibodies

2:35 pm Speaker Q&A

2:45 pm Closing Remarks

3:00 pm End of Workshop